116 results
The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
Primary objectiveTo determine whether the clinical response after 10-day oral administration of cadazolid is non-inferior to oral vancomycin in subjects with CDAD.Secondary objectivesTo determine whether oral administration of cadazolid for 10 days…
The primary objectives of this study are:* To evaluate tracer kinetic models for the purpose of quantifying specific binding of 18F-AV-1451 in cross sectional and longitudinal applications; and* To evaluate simplified methods for quantification of…
The primary objective of this confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid, within the stomach.
The primary objective of the study is Study to determine the Safety, Tolerability, Pharmacokinetics and Effect on Circulating Alpha-1 Antitrypsin Levels of ARC-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD)
Primary Objective To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo adjuvanted with imiquimod, to induce HPV 16 and 18 viral clearance at 12 months in HPV 16 and/or 18 infected women using a type specific,…
This study is set-up to evaluate the safety and tolerability of CCX168 in subjects with mild to moderate AARV on a background of cyclophosphamide treatment. It will assess the possibility to optimize the treatment with CCX168 and to reduce the side…
The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of CIDP compared with placebo. Data from this study will be used to support the registration of fingolimod in the indication of CIDP.
Primary objectiveThe primary objective of the study is to estimate the effects of tofacitinib in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn*s disease previously achieving clinical response or…
PrimaryTo compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 and bevacizumab in combination withmFOLFOX6 based on investigator radiological tumor assessmentSecondary• Progression Free Survival (PFS) based on…
Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients withMild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease
Objectives:Primary:• To determine the absolute bioavailability of niraparib by using an intravenous (IV) niraparibmicrodose of 100 µg (containing approximately 1 µCi of [14C]-niraparib) in subjects with cancer.Secondary:• To characterize the…
The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator*s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have relapsed…
The primary objective of this study is:To confirm the effect of Tasquinimod on delaying disease progression or death compared with placebo.The secondary objectives of this study are:• To determine the effect of Tasquinimod on overall survival, time…
The primary objective is:Assess the efficacy defined as Composite Complete Response (CRc)The secondary objectives of this study are:* Assess safety and tolerability* Assess immunogenicity and pharmacokinetics* Progression-free survival (PFS),…
The evaluation of the safety and pharmacokinetics of ABT-414 in combination with radiation plus temozolomide or temozolomide alone for subjects with Glioblastoma Multiforme.
To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension (PAH).
The objective of this exploratory study is to investigate the acid neutralisation action of sodium alginate oral suspension versus placebo liquid, within the stomach and to assess suitability and robustness of the pH monitoring methodology.
Primary:1. To assess the pharmacokinetic profiles following single dose administration of MK-8408 administered as a PMF1 tablet by means of AUC0-*, AUClast, AUC0-24, Cmax, C24, tmax, and t* under fed conditions, following a high fat meal. 2. To…
The purpose of this studie is to evaluate the bioequivalence of canagliflozin.